Total Hip Replacement {SS316L} - India CDSCO Medical Device Registration

Total Hip Replacement {SS316L} is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000537_a5f66492f6287755d1919eeee3751240_c4e1e2cfb2400a9e2ca06be5c327514e. This device is marketed under the brand name Wings Ortho. The license holder is Orthoflex Medisys India Pvt Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

Total Hip Replacement {SS316L}

UID: MFG/MD/2023/000537_a5f66492f6287755d1919eeee3751240_c4e1e2cfb2400a9e2ca06be5c327514e

Brand Name

Wings Ortho

License Holder

Orthoflex Medisys India Pvt Ltd

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Total Hip Replacement (Wings Ortho) is intended for use in the total hip arthroplasty and is intended for pressfit (Wings Ortho) use. Total hip arthroplasty is intended to provide increase patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to sit and support the components. Total hip replacement is indicated in the following conditions.(Wings Ortho) Correction of function deformity. (Wings Ortho) Non inflammatory degenerative joint disease (Wings Ortho) including osteoarthritis, traumatic/Rheumatoid arthritis, congenital hip dysplasia and avascular necrosis. (Wings Ortho) Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement unmanaged by other procedures. (Wings Ortho) revision procedure when other devices are failed.

Class C

Bone wires, Pins & Staples

Brand: Wings Ortho

Orthoflex Medisys India Pvt Ltd

Class C

Brand: Wings Ortho

Class C